SAB Biotherapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 7, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0000950170-25-067554
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0000950170-25-104566
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 85 previous paragraphs and 90 current paragraphs.
51 unchanged; 21 reworded; 13 added; 11 removed; 2 previous and 5 current paragraphs rearranged.
Tables are not compared: 9 previous and 17 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (13)
Current report
SAB-142: Our Lead Product Candidate
Current report
Our wholly owned lead product candidate, SAB-142 is a human anti-thymocyte globulin (ATG) focused on preventing or delaying the progression of T1D. SAB-142 is a first-in-class, human, multi-target ATG treatment designed to provide superior efficacy and safety in delaying the onset or progression of T1D. SAB-142 is expected to reduce autoimmune β-cell destruction and delay progression or onset of T1D in patients with Stage 3 or Stage 2 T1D, respectively. The mechanism of action of SAB-142 has been clinically validated in numerous clinical trials with a rabbit anti-thymocyte globulin (rATG). In addition, data from more than 700 human subjects treated with antibodies produced by our platform support expectation of a zero-serum sickness rate and zero incidence of neutralizing anti-drug antibodies (ADA) within the upcoming SAB-142 clinical trials.
Current report
We received an Investigational New Drug (IND) clearance from the FDA in May 2024 and announced positive topline data from our Phase 1 clinical trial of SAB-142 in January 2025. Next, we intend to advance SAB-142 into a Phase 2b clinical trial called the SAFEGUARD study. On May 29, 2025, the Company held a constructive Type B meeting with the FDA. The meeting followed positive topline data from a Phase 1 single-ascending dose trial in healthy volunteers for SAB-142. The primary discussion centered on questions related to all aspects of SAB-142’s Phase 2b SAFEGUARD clinical trial design and chemistry, manufacturing, and controls processes. The FDA provided clear, constructive, and actionable guidance during the discussion leading to alignment on the design and advancement of our Phase 2b SAFEGUARD study. SAB confirmed its intent with the FDA to utilize the data from this study as supportive evidence for future regulatory approval.
Current report
Other Immunology Indications
Current report
T- and B-cells are multifunctional lymphocytes whose dysregulation was shown to have a central role in the pathogenesis of more than 80 autoimmune diseases, including T1D, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), multiple sclerosis (MS) and celiac disease. The therapeutic success to date of lymphocyte- mediating therapies in variety of autoimmune diseases and our in vivo and in vitro pre-clinical and Phase 1 work from SAB-142 in T1D will support direct progression into Phase 2 clinical trials in other autoimmune indications.
Current report
Since the commencement of our operations, we have devoted substantially all of our resources to research and development activities, organizing and staffing our company, business planning, raising capital, establishing and maintaining our intellectual property portfolio, conducting preclinical studies and clinical trials and providing general and administrative support for these operations.
Current report
Research and development expenses decreased by $0.1 million, or 0.8% for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The year-over-year change includes a decreases in outside lab services (year-over-year decrease of $2.2 million, 70.2%), overhead (year-over-year decrease of $1.5 million, 26.5%), project consulting (year-over-year decrease of $0.1 million, 26.5%), laboratory supplies (year-over-year decrease of $0.3 million, 50.7%), animal care (year-over-year decrease of $0.1 million, 54.5%), offset by an increase in salaries and benefits (year-over-year increase of $1.7 million, 37.1%) and clinical trial costs (year-over-year increase of $2.4 million, (167.7%). We expect Research and Development expenses to increase in future years as we advance our lead therapeutic candidate through Phase 2 clinical trials and invest in the necessary foundation to support potential commercialization.
Current report
General and administrative expenses decreased by $2.2 million, or 27.2%, in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to salaries and benefits (year-over-year decrease of $0.9 million, 22.6%), insurance costs (year-over-year decrease of $0.2 million, 22.6%) and other immaterial administrative support fees relating to IT and human resources (year-over-year decrease of $1.2 million, 42.5%) offset by an increase in project consulting (year-over-year decrease of $0.1 million, 15.6%).
Current report
Total non-operating income decreased by $3.3 million, or (38.43)%, in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to the change in fair value of warrant liabilities (year-over-year decrease of $3.3 million, 42.6%). The Australian research and development tax credit and dividend income for the six months ended June 30, 2025 was consistent with the Australian research and development tax credit and dividend income for the six months ended June 30, 2024.
Current report
On July 21, 2025, the Company entered into the July 2025 Purchase Agreement with certain accredited investors, pursuant to which the Company agreed to issue and sell, in the Series B Offering, (i) 1,000,000 Series B Shares, convertible into 100,000,000 Series B Conversion Shares, (ii) the Release Date Warrants to purchase up to 500,000 the Release Date Warrant Shares, and (iii) the Enrollment Date Warrants to purchase up to 1,000,000 Release Date Warrant Shares. The Company generated approximately $175 million in gross proceeds, before fees and expenses, from the Series B Offering. The Series B Preferred Stock is convertible into common stock, subject to stockholder approval. The net proceeds are intended to fund the Phase 2b SAFEGUARD study of SAB-142 and for general corporate purposes.
Current report
See Note20, Subsequent Events, in our condensed consolidated financial statements for more information about the Series B Offering.
Current report
Shelf Registration Statement
Current report
On May 3, 2023, we filed a Registration Statement on Form S-3 (Registration No. 333-271768) (the “Shelf Registration Statement”), declared effective on May 17, 2025 by the SEC, which includes a base prospectus that allows us to offer and sell, from time to time, in one or more offerings, common stock, preferred stock, debt securities, warrants, rights or units up to an aggregate public offering price of $50.0 million. The Shelf Registration Statement is intended to preserve our flexibility to raise capital from time to time, if and when needed. On January 26, 2024, we entered into a Controlled Equity Offering℠ Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), relating to shares of our common stock registered for sale under the Shelf Registration Statement. In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $20.0 million from time to time through Cantor, acting as our sales agent.
Removed paragraphs (11)
Previous report
Recent Developments
Previous report
Since its recent announcement of positive topline data results for the Phase 1 clinical trial of SAB-142 on January 28, 2025, SAB BIO provided a clinical trial progress update on DATE SAB BIO announced patient dosing concluded in the last cohort of the Phase 1 clinical study of SAB-142.
Previous report
Given SAB-142 was generally well-tolerated among healthy volunteers and data from Phase 1 trial confirms SAB-142 does not cause serum sickness or anti-drug antibodies at target dose, we maintain that study results support that SAB-142 is well-positioned for re-dosing in outpatient setting for type 1 diabetes. Based on the data, SAB BIO plans to advance SAB-142 into a Phase 2b trial in 2025 to evaluate the therapeutic candidate in adult and pediatric patients with new-onset T1D.
Previous report
Corporate Strategy
Previous report
Our proprietary platform represents the first technology of its kind to produce large-scale human high-titer and high-avidity antibodies across multiple modalities. Leveraging our proprietary production system will help us advance a robust pipeline of differentiated hIgG-based therapies for the treatment of immune system disorders and infectious diseases. Our hIgGs have been safely demonstrated in Phase 3 clinical trials with a patient safety database that includes over 700 patients who were safely administered our hIgG therapeutics.
Previous report
We have a demonstrated regulatory pathway through each of the FDA, CBER, UK Medicines and Healthcare products Regulatory Agency (“MHRA”), and Australian Therapeutic Goods Administration (“TGA”). These organizations understand our science and are familiar with the multivalent and multitarget properties of our single vial drug products. This further streamlines our ability to develop new and novel drug products rapidly and efficiently where single target monoclonal antibodies (“mAbs”) cannot replicate or duplicate our drug product attributes.
Previous report
We believe that our financial performance has been, and in the foreseeable future will continue to be, primarily driven by multiple factors as described throughout our analysis within Components of Results of Operations below, each of which presents growth opportunities for our business. These factors also pose important challenges that we must successfully address in order to sustain our growth and improve our results of operations. Our ability to successfully address these challenges is subject to various risks and uncertainties, including those described in the section captioned “Part I, Item 1A, Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and supplemented with revised or additional risk factors in our Quarterly Reports on Form 10-Q, including any such risks included in “Part II, Item 1A, Risk Factors” herein.
Previous report
As of March 31, 2025 and December 31, 2024, we had $12.9 million and $20.8 million, respectively, of cash, cash equivalents, and investments.
Previous report
We intend to continue to invest in our business and, as a result, may incur operating losses in future periods. We expect to continue to invest in research and development efforts towards expanding our capabilities and expertise along our platform and the primary pipeline development targets we are working on, as well as building our business development team and marketing our solutions to partners in support of the growth of the business.
Previous report
We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin commercialization of our products. As a result, we will require additional capital to fund our operations in order to support our long-term plans.
Previous report
We currently expect that our cash, cash equivalents, and short-term investments of $12.9 million as of March 31, 2025 will not be sufficient to fund our operating expenses and capital requirements for more than 12 months from the date the financial statements are issued. These conditions raise substantial doubt about our ability to continue as a going concern.
Reworded paragraphs (21)
Previous wording
We are a clinical-stage biopharmaceutical company focused on the development of human polyclonal immunotherapeutic antibodies, or human immunoglobulins (hIgG), to address immunology disorders. Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs. We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases, including type 1 diabetes (T1D) and other autoimmune disorders. Our internally discovered antibodies are both target-specific and polyclonal, meaning they are comprised of multiple hIgGs and can bind to multiple sites on targeted immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders.
Current wording
We are a clinical-stage biopharmaceutical company focused on developing human, multi-specific, high-potency immunoglobulins (IgGs), without the need for human donors or convalescent plasma, to treat and prevent autoimmune disorders. Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs. We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases, including type 1 diabetes (T1D) and other autoimmune disorders. Our internally discovered antibodies are multi-specific, meaning they are comprised of multiple human IgG (hIgG) and can bind to multiple sites on targeted immunogens, making them ideally suited to address the complexities associated with many immune-mediated disorders.
Previous wording
Our proprietary platform, referred to as holds the potential to generate additional novel therapeutic candidates to expand our pipeline. Our platform utilizes the human immune response to generate the optimal repertoire of IgGs for drug targets of interest. We believe it is the only technology capable of producing disease-targeted, hIgG in large quantities without the need for human plasma donors. We have optimized genetic engineering in the development of transchromosomic cattle, or Tc Bovine, which produce hIgGs. Our engineering of our production platform drives IgG1 production across our pipeline. In addition, this differentiated approach using polyclonal antibodies has no biosimilar pathway which provides a significant barrier to competitive polyclonal approaches.
Current wording
Our proprietary platform holds the potential to generate additional novel therapeutic candidates to expand our pipeline, utilizing the human immune response to generate the optimal repertoire of hIgG for drug targets of interest. We believe it is the only technology capable of producing disease-targeted, hIgG in large quantities without the need for human plasma donors. We have optimized genetic engineering in the development of transchromosomic cattle, or Tc Bovine, which produce hIgG. Our engineering of our production platform drives IgG1 production across our pipeline. In addition, this differentiated approach using polyclonal antibodies has no biosimilar pathway, which provides a significant barrier to competitive polyclonal approaches.
Previous wording
There was no revenue recognized for the three months ended March 31, 2025. Total revenue recognized from government grants was approximately $0.9 million for the three months ended March 31, 2024. The Company had various grants from the US Department of Defense that terminated in 2022. The Company satisfied all obligations under these arrangements as of December 31, 2024.
Current wording
There was no revenue recognized for the three and six months ended June 30, 2025. Total revenue recognized from government grants was approximately $0.3 million and $1.2 million for the three and six months ended June 30, 2024, respectively. The Company had various grants from the US Department of Defense that terminated in 2022. The Company satisfied all obligations under these arrangements as of December 31, 2024.
Previous wording
Research and development activities consist of discovery research for our platform development and the indications we are working on. For SAB-142, Avance Clinical PTY, Ltd (“Avance”), acts as the contract research organization (“CRO”) overseeing our Phase 1 safety study. This study started in December 2023 and the terms of that agreement are subject to confidentiality and the status of the agreement is that it is current. For the three months ended March 31, 2025 and 2024, we continued to incur costs to advance our progress towards commercialization of SAB-142. We expect to continue to incur substantial research and development expenses as we conduct discovery research to enhance our platform and work on our indications. We expect to hire additional employees and continue research and development and manufacturing activities. As a result, we expect that our research and development expenses will continue to increase in future periods and vary from period to period.
Current wording
For the three and six months ended June 30, 2025 and 2024, we continued to incur costs to advance our progress towards commercialization of SAB-142. We expect to continue to incur substantial research and development expenses as we conduct discovery research to enhance our platform and work on our indications. We expect to hire additional employees and continue research and development and manufacturing activities. As a result, we expect that our research and development expenses will continue to increase in future periods and vary from period to period.
Previous wording
Research and development expenses by component for the three months ended March 31, 2025 and 2024:
Current wording
Research and development expenses by component for the three and six months ended June 30, 2025 and 2024:
Previous wording
Comparison of the three months ended March 31, 2025 and 2024
Current wording
Comparison of the three and six months ended June 30, 2025 and 2024
Previous wording
Revenue decreased by $0.9 million, or 100.0%, in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, due to the JPEO Rapid Response Contract Termination. There was no revenue recognized for the three months ended March 31, 2025. Included in revenues for the three months ended March 31, 2024, are closeout activities and charges of $0.9 million due to outside services for laboratory supply disposal.
Current wording
Revenue decreased by $0.3 million, or 100.0%, in the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, due to the JPEO Rapid Response Contract Termination. There was no revenue recognized for the three months ended June 30, 2025. Included in revenues for the three months ended June 30, 2024, are closeout activities and charges of $0.3 million due to outside services for laboratory supply disposal.
Previous wording
Research and development expenses decreased by $0.5 million, or 6.0%, for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to decreases in outside lab services (year-over-year decrease of $0.9 million, 56.8%), a decrease of an out-of-period adjustment of $0.2 million of amortization expense, overhead (year-over-year decrease of $1.2 million, 35.3%), project consulting (year-over-year decrease of $0.1 million, 35.3%), laboratory supplies (year-over-year decrease of $0.1 million, 32.0%) offset by an increase in salaries and benefits (year-over-year increase of $0.9 million, 41.5%) and clinical trial costs (year-over-year increase of $1.1 million, (139.1%). We expect Research and Development expenses to increase in future years as we advance our lead therapeutic candidate through Phase 2 clinical trials and invest in the necessary foundation to support potential commercialization.
Current wording
Research and development expenses increased by $0.2 million, or 2.6%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to an increase in salaries and benefits (year-over-year increase of $0.8 million, 33.0%) and clinical trial costs (year-over-year increase of $1.2 million, 204.3%), offset by decreases in outside lab services (year-over-year decrease of $1.2 million, 85.8%), overhead (year-over-year decrease of $0.3 million, 16.7%), animal care (year-over-year decrease of $0.1 million, 62.4%), and laboratory supplies (year-over-year decrease of $0.2 million, 71.8%). We expect Research and Development expenses to increase in future years as we advance our lead therapeutic candidate through Phase 2 clinical trials and invest in the necessary foundation to support potential commercialization.
Previous wording
General and administrative expenses decreased by $1.1 million, or 25.6%, in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to salaries and benefits (year-over-year decrease of $0.5 million, 25.0%), project consulting (year-over-year decrease of $0.1 million, 28.7%), insurance costs (year-over-year decrease of $0.1 million, 25.3%) and other immaterial administrative support fees relating to IT and human resources (year-over-year decrease of $0.4 million, 25.9%).
Current wording
General and administrative expenses decreased by $0.9 million, or 24.9%, in the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to salaries and benefits (year-over-year decrease of $0.4 million, 19.9%), insurance costs (year-over-year decrease of $0.1 million, 19.7%), other immaterial administrative support fees relating to IT and human resources (year-over-year decrease of $0.6 million, 51.7%), offset by an increase in project consulting (year-over-year increase of $0.2 million, 103.2%).
Previous wording
Total non-operating income decreased by $0.4 million, or (6.07)% in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to the change in fair value of warrant liabilities (year-over-year decrease of $0.4 million, 7.9%), offset by a $0.1 million increase in the Australian research and development tax credit.
Current wording
Total non-operating income decreased by $2.9 million, or 112.8%, in the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to the change in fair value of warrant liabilities (year-over-year decrease of $2.8 million 128.3%), and a net decrease of $0.1 million in the Australian research and development tax credit and dividend income.
Previous wording
Interest income decreased by $0.4 million, or (87.45)%, during the three months ended March 31, 2025 as compared to the three months ended March 31, 2025, primarily due to interest earned on our investments in debt securities, and lower interest earning cash, and cash equivalent balances.
Current wording
Interest income decreased by $0.4 million, or 96.4%, during the three months ended June 30, 2025, as compared to the three months ended June 30, 2024, primarily due to interest earned on our investments in debt securities, and lower interest earning cash, and cash equivalent balances.
Previous wording
The accompanying unaudited condensed consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. We have experienced net losses, negative cash flows from operations and, as of March 31, 2025, and had an accumulated deficit of $129.4 million. We anticipate we will continue to generate losses for the foreseeable future and expect the losses to increase as we continue the development of, or seek regulatory approvals for, product candidates, and begin commercialization of products. As a result, we will require additional capital to fund operations in order to support our long-term plans.
Current wording
The Company has experienced net losses, negative cash flows from operations and, as of June 30, 2025, had an accumulated deficit of $139.5 million. The Company anticipates that it will continue to generate losses for the foreseeable future, and expects the losses to increase as the Company continues the development of, or seeks regulatory approvals for product candidates, and begins commercialization of products. As a result, the Company will require additional capital to fund operations in order to support long-term plans.
Previous wording
We will need to raise additional capital to fund our operations, continue to execute our strategy, and continue as a going concern. In the future, we may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative, or other funding arrangements. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.
Current wording
Based on the Company’s current level of operating expenses, existing resources will be sufficient to cover operating cash needs through the twelve months following the date of this report. In the future, the Company may seek additional funding through a combination of equity or debt financings, or other third-party financing, collaborative or other funding arrangements. Should the Company seek additional financing from outside sources, the Company may not be able to raise such financing on terms acceptable to the Company or at all. If the Company is unable to raise additional capital when required or on acceptable terms, the Company may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.
Previous wording
At March 31, 2025 and December 31, 2024, we recognized approximately $139 thousand and $276 thousand, respectively, as an insurance financing note payable in our condensed consolidated balance sheets. We incurred $4 thousand and $8 thousand of interest expense related to the insurance financing note for the three months ended March 31, 2025 and 2024, respectively. Our current insurance financing agreement is being repaid through installment payments, with the final payment scheduled for September 22, 2025.
Current wording
We did not have an insurance financing note payable at June 30, 2025. At December 31, 2024, we recognized approximately $276 thousand, as an insurance financing note payable in our condensed consolidated balance sheets. We incurred $1 thousand and $6 thousand of interest expense related to the insurance financing note for the three and six months ended June 30, 2025, respectively, and $4 thousand and $12 thousand for the three and six months ended June 30, 2024, respectively. Our current insurance financing agreement was repaid through installment payments, with the final payment on June 22, 2025.
Previous wording
In 2023, we entered into an agreement with First Insurance Funding, which assigned them a first-priority lien on the security interest in the financed policies and associated rights. During the three months ended March 31, 2024, we made payments on the prior insurance financing agreement with First Insurance Funding with an original principal balance of $765 thousand and an annual interest rate of 7.96%. This prior agreement, structured with similar lien and collateral terms, was fully repaid upon the final installment on September 22, 2024
Current wording
In 2023, we entered into an agreement with First Insurance Funding, which assigned them a first-priority lien on the security interest in the financed policies and associated rights. During the six months ended June 30, 2024, we made payments on the prior insurance financing agreement with First Insurance Funding with an original principal balance of $765 thousand and an annual interest rate of 7.96%. This prior agreement, structured with similar lien and collateral terms, was fully repaid upon the final installment on September 22, 2024
Previous wording
The following table summarizes our cash flows for the three months ended March 31, 2025 and 2024:
Current wording
The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024:
Previous wording
Net cash used in operating activities increased by $3.0 million in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to a decrease in cash used in operating activities related to change in our operating assets and liabilities of $3.8 million and an increase in our net loss adjusted for non-cash items of $0.9 million. Year-over-year changes in cash used by operating activities is explained by shifts in the working capital balances as we continue to invest in the development of our lead product candidate, SAB-142.
Current wording
Net cash used in operating activities decreased by $3.5 million in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to a decrease in cash used in operating activities related to change in our operating assets and liabilities of $4.5 million, offset by an increase in our net loss adjusted for non-cash items of $1.0 million. Year-over-year changes in cash used by operating activities is explained by shifts in the working capital balances as we continue to invest in the development of our lead product candidate, SAB-142.
Previous wording
Net cash used by investing activities increased by $36.0 million in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to increased purchases of short-term investments following the completion of the September 2023 Offering. Capital expenditures were minimal in 2024, as major asset purchases in prior years were primarily related to leasehold improvements at our corporate headquarters. We do not anticipate a significant increase in capital asset purchases in the near term, as our investment focus remains on advancing our lead therapeutic candidate through Phase 2 clinical trials.
Current wording
Net cash used by investing activities decreased by $30.0 million in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to decreased purchases of short-term investments. Capital expenditures were minimal through the six months ended June 30, 2025. We do not anticipate a significant increase in capital asset purchases in the near term, as our investment focus remains on advancing our lead therapeutic candidate through Phase 2 clinical trials.
Previous wording
Net cash used by financing activities decreased by $0.2 million in the three months ended March 31, 2025 as compared to the three months ended March 31, 2024, primarily due to the absence of any material equity financing activities in 2024.
Current wording
Net cash used by financing activities decreased by $0.4 million in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to the decrease in payments on the insurance financing note.
Previous wording
We continue to record a valuation allowance on its net deferred tax assets. The valuation increased by approximately $2.5 million during the three months ended March 31, 2025. We have not recognized any reserves for uncertain tax positions.
Current wording
We continue to record a valuation allowance on its net deferred tax assets. The valuation increased by approximately $4.5 million during the six months ended June 30, 2025. We have not recognized any reserves for uncertain tax positions.
Previous wording
Our most critical accounting estimates and assumptions are included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025. There have been no significant changes to our critical accounting policies during the three months ended March 31, 2025. See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements for further details.
Current wording
Our most critical accounting estimates and assumptions are included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 31, 2025 and our most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 9, 2025. There have been no significant changes to our critical accounting policies during the three months ended June 30, 2025. See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements for further details.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
Research and development activities consist of discovery research for our platform development and the indications we are working on. For SAB-142, Avance Clinical PTY, Ltd (“Avance”), acts as the contract research organization (“CRO”) overseeing our Phase 1 safety study. This study started in December 2023 and the terms of that agreement are subject to confidentiality and the status of the agreement is that it is current. Pursuant to an agreement between the Company and Fortrea Holdings Inc. (“Fortrea”). Fortrea will act as the CRO overseeing our Phase 2b efficacy and safety study for SAB-142. The study is expected to start in December 2025.
Current report — wording carried from elsewhere
The following tables set forth our results of operations for the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
Revenue decreased by $1.2 million, or 100.0%, in the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, due to the JPEO Rapid Response Contract Termination. There was no revenue recognized for the six months ended June 30, 2025. Included in revenues for the six months ended June 30, 2024, are closeout activities and charges of $1.2 million due to outside services for laboratory supply disposal.
Current report — wording carried from elsewhere
Interest expense in the six months ended June 30, 2025 was consistent with interest expense in the six months ended June 30, 2024.
Current report — wording carried from elsewhere
Interest income decreased by $0.8 million, or (91.28)%, during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to interest earned on our investments in debt securities, and lower interest earning cash, and cash equivalent balances.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
We are focused on developing product candidates for disease targets where a differentiated approach has the greatest potential to be either first-in-class against novel targets or best-in-class against complex targets to treat diseases with significant unmet medical needs, including immune and autoimmune disorders including T1D. Our business strategy is focused on SAB-142 as a first-in-class, human, multi-target antibody treatment designed to provide superior efficacy and safety in delaying the onset or progression of T1D.
Previous report — wording carried elsewhere
We have incurred operating losses for the past several years. While we intend to continue to keep operating expenses at a reduced level there can be no assurance that our current level of operating expenses will not increase or that other uses of cash will not be necessary. Based on our current level of operating expenses, existing resources will not be sufficient to cover operating cash needs through the twelve months following the date these financials are made available for issuance. These conditions raise substantial doubt about our ability to continue as a going concern. We intend to seek additional capital through equity and/or debt financings, collaborative or other funding arrangements. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate our assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.